Objective: To evaluate the long-term efficacy and safety of niraparib in Japanese women with heavily pretreated ovarian cancer. Methods: This was the follow-up analysis of a phase 2, multicenter, open-label, single-arm study in Japanese women with homologous recombination-deficient, platinum-sensitive, relapsed, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who had completed 3–4 lines of chemotherapy and were poly(ADP-ribose) polymerase inhibitor naïve. Participants received niraparib (starting dose, 300 mg) once daily in continuous 28-day cycles until objective disease progression, unacceptable toxicity, or consent withdrawal. The primary endpoint was confirmed objective response rate (ORR), as assessed using Response Evaluation Criteria in Solid Tumors version 1.1. Safety evaluations included treatment-emergent adverse events (TEAEs). Results: 20 patients were enrolled in the study and included in both efficacy and safety analyses. Median total study duration was 759.5 days. Median dose intensity was 201.3 mg/ day. Confirmed ORR was 60.0% (90% confidence interval [CI]=39.4–78.3); 2 patients had complete response and 10 patients had partial response. Median duration of response was 9.9 months (95% CI=3.9–26.9) and the disease control rate was 90.0% (95% CI=68.3–98.8).The most common TEAEs were anemia (n=15), nausea (n=12), and decreased platelet count (n=11). TEAEs leading to study drug dose reduction, interruption, or discontinuation were reported in 16 (80.0%), 15 (75.0%), and 2 patients (10.0%), respectively. Conclusion The long-term efficacy and safety profile of niraparib was consistent with previous findings in the equivalent population in non-Japanese patients. No new safety signals were identified.

Objective: To evaluate the long-term efficacy and safety of niraparib in Japanese women with heavily pretreated ovarian cancer. Methods: This was the follow-up analysis of a phase 2, multicenter, open-label, single-arm study in Japanese women with homologous recombination-deficient, platinum-sensitive, relapsed, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who had completed 3–4 lines of chemotherapy and were poly(ADP-ribose) polymerase inhibitor naïve. Participants received niraparib (starting dose, 300 mg) once daily in continuous 28-day cycles until objective disease progression, unacceptable toxicity, or consent withdrawal. The primary endpoint was confirmed objective response rate (ORR), as assessed using Response Evaluation Criteria in Solid Tumors version 1.1. Safety evaluations included treatment-emergent adverse events (TEAEs). Results: 20 patients were enrolled in the study and included in both efficacy and safety analyses. Median total study duration was 759.5 days. Median dose intensity was 201.3 mg/ day. Confirmed ORR was 60.0% (90% confidence interval [CI]=39.4–78.3); 2 patients had complete response and 10 patients had partial response. Median duration of response was 9.9 months (95% CI=3.9–26.9) and the disease control rate was 90.0% (95% CI=68.3–98.8).The most common TEAEs were anemia (n=15), nausea (n=12), and decreased platelet count (n=11). TEAEs leading to study drug dose reduction, interruption, or discontinuation were reported in 16 (80.0%), 15 (75.0%), and 2 patients (10.0%), respectively. Conclusion The long-term efficacy and safety profile of niraparib was consistent with previous findings in the equivalent population in non-Japanese patients. No new safety signals were identified.

Objective: To evaluate the long-term efficacy and safety of niraparib in Japanese women with heavily pretreated ovarian cancer. Methods: This was the follow-up analysis of a phase 2, multicenter, open-label, single-arm study in Japanese women with homologous recombination-deficient, platinum-sensitive, relapsed, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who had completed 3–4 lines of chemotherapy and were poly(ADP-ribose) polymerase inhibitor naïve. Participants received niraparib (starting dose, 300 mg) once daily in continuous 28-day cycles until objective disease progression, unacceptable toxicity, or consent withdrawal. The primary endpoint was confirmed objective response rate (ORR), as assessed using Response Evaluation Criteria in Solid Tumors version 1.1. Safety evaluations included treatment-emergent adverse events (TEAEs). Results: 20 patients were enrolled in the study and included in both efficacy and safety analyses. Median total study duration was 759.5 days. Median dose intensity was 201.3 mg/ day. Confirmed ORR was 60.0% (90% confidence interval [CI]=39.4–78.3); 2 patients had complete response and 10 patients had partial response. Median duration of response was 9.9 months (95% CI=3.9–26.9) and the disease control rate was 90.0% (95% CI=68.3–98.8).The most common TEAEs were anemia (n=15), nausea (n=12), and decreased platelet count (n=11). TEAEs leading to study drug dose reduction, interruption, or discontinuation were reported in 16 (80.0%), 15 (75.0%), and 2 patients (10.0%), respectively. Conclusion The long-term efficacy and safety profile of niraparib was consistent with previous findings in the equivalent population in non-Japanese patients. No new safety signals were identified.

Following the revision of the structure and content of the Model Core Curriculum for Medical Education to be more outcome-based and the legal status of the medical practice performed by medical students in the clinical clerkship, we have revised the Guideline for Participatory Clinical Clerkship. The following items were revised or newly described : significance of enhancing the participatory clinical clerkship, scope of medical practice, confidentiality, patient consent, patient consultation and support service, objectives of the clinical clerkship, simulation education, departments where the clinical clerkship is conducted, assessment in the clinical practice setting, CC-EPOC, and entrustable professional activities. A foundation has been established to promote seamless undergraduate and postgraduate medical education. However, future work is needed to examine the specific level of performance expected at the end of the clinical clerkship and department-specific clinical practice goals and educational strategies.

In the 2022 revision of the Model Core Curriculum, a new "Educational Strategies and Assessment" section was added as a further development in outcome-based education. By adding a chapter on strategies and evaluation, which is an important element of the curriculum, and linking it to qualities and abilities, we have devised a way for learners and instructors to make use of the Core Curriculum more easily. In addition, 11 example of strategy and assessment cases are included as Good Practice to encourage practical application. However, since these are only examples, we hope this chapter will be further developed as universities create strategies and evaluations that make the most of their unique characteristics.

The Model Core Curriculum (Core Curriculum) is a "model" that systematically organizes the "core" parts of a university "curriculum," which all universities should work on in common. This section describes the part of the Core Curriculum revision that is related to digital transformation (DX). In order to disseminate the Core Curriculum, prepare for future changes, and support the collaborative work of many experts, the DX of the Core Curriculum included the introduction of data and the digitalization of the Core Curriculum work process. The digitization of the core curricula has made it possible to search for and browse through them on a website, distribute them in multiple formats such as Excel files and csv files, and link them to various software such as electronic syllabi and data analysis software. The digitalization of the work process has enabled multiple members to revise the core curricula in parallel. In the future, more personnel will need to support the introduction of such digital technology and a wider range of data.

Purpose : The aim of this study is to evaluate the outcome of aortic valve replacement (AVR) with ascending aorta grafting under hypothermic circulatory arrest for patients with shaggy/calcified ascending aorta based on preoperative and intraoperative assessment of ascending aorta. Methods : From April 2010 to July 2019, 133 patients with aortic stenosis underwent AVR. Based on preoperative computed tomography and intraoperative epi aortic ultrasound, 121 patients were able to have their aorta clamped (C-AVR), while clamping was not possible for 12 patients due to shaggy/calcified in the ascending aorta (Asc-AVR). In Asc-AVR, ascending aorta was replaced to the vascular graft under hypothermic circulatory arrest with retrograde cerebral perfusion followed by AVR. Results : Although operative time and cardiopulmonary bypass time were prolonged and blood transfusion volume was significantly high in Asc-AVR, there were no significant differences in postoperative complications. Although postoperative MRI revealed two silent strokes, no symptomatic neurologic complications occurred in Asc-AVR. Five-year survival rates between groups were comparable (64.2% in Asc-AVR vs. 79.9% in C-AVR, p=0.420). Replacement of ascending aorta was not a risk factor of late death. Conclusion : AVR with ascending aorta grafting under hypothermic circulatory arrest based on preoperative and intraoperative assessment of ascending aorta is an acceptable method for patients with shaggy/calcified aorta.

In career education, devising ways to elicit proactive participation is vital, thus we conducted face-to-face workshops to drive learners’ participation. However, the COVID-19 pandemic forced us to teach classes online. Therefore, to motivate more than 100 students to participate actively in the online format, we conducted career education using Active Book Dialogue® where several students read a book together in a short period of time. Each student read a specific part of the book they were assigned and summarized it in collaboration with their group members. This enabled them to learn career theory. Additionally, the online format allowed several lectures to be held within a remote and interactive environment. We will reflect on this experience and report on how this can be applied in other schools.

The faculty development for clinical supervisor teaching residents (FD) was held for two nights on site in Japan. However, corona pandemic made it difficult to conduct the FD on site, thus we conducted it completely online. To avoid participants’ burden of long hours of synchronous online learning, we adopted a flipped classroom in which assignments in asynchronous online learning was used in discussion in synchronous learning. Assignments were issued sequentially five weeks prior to the synchronous session, and the synchronous session was held from 5:00 p.m. on Friday, November 13, 2020 to Saturday, November 14, 2020 for 45 participants. All participants completed the course by submitting all the assignments. The online flipped classroom utilizing assignments has a potential to significantly reduce the time constraints on busy clinicians.